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Treatment of Mood and Marriage Study (TOMMS)

Primary Purpose

Major Depressive Disorder, Partner Relational Disorder (V61.10)

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Weekly marital therapy
As indicated: Sertraline, bupropion, venlafaxine, mirtazepine, nortriptyline, tranylcypromine, lithium augmentation, etc.
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Older Adults

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • One partner must receive a clinical diagnosis of major depressive disorder based upon our assessment
  • Couples must be living together
  • Either partner must report marital distress or tension
  • Willing to take antidepressant medication and participate in weekly marital therapy and assessments
  • The depressed partner cannot be involved in any other psychosocial treatment
  • Score above 24 on the Mini Mental Status Exam

Exclusion Criteria:

  • Both partners meet diagnostic criteria for major depressive disorder based on our evaluation
  • Coexisting bipolar or psychotic disorder
  • Evidence of a primary substance abuse or dependence disorder
  • Current ECT treatment
  • Evidence of active and severe domestic violence

Sites / Locations

  • Duke Child & Family Studies Center; Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Combination

Arm Description

Medication management with a study doctor every other week.

Medication management with a study doctor every other week plus weekly marital therapy.

Outcomes

Primary Outcome Measures

Hamilton Depression Rating Scale (HDRS)
The HDRS is a semi-structured interview administered by a trained independent evaluator, and used for rating the severity of depressive symptoms. Scores range from 0 to 50, with higher scores indicating greater severity of depression.
Dyadic Adjustment Scale (DAS)
The DAS is a self-report measure of marital adjustment that includes questions about agreement on lifestyle and household decisions, level of conflict, level of cooperation, and affection. Scores range from 0 to 151, with higher scores representing better relationship functioning.

Secondary Outcome Measures

Frequency & Acceptability of Partner Behavior
Conflict Tactics Scale
SCID Mood Disorders
Personal Assessment of Intimacy in Relationships
Beck Anxiety Inventory

Full Information

First Posted
January 2, 2008
Last Updated
June 17, 2013
Sponsor
Duke University
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00612807
Brief Title
Treatment of Mood and Marriage Study (TOMMS)
Official Title
Adapting Marital Therapy in Older Adults With Depression
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary goal of this study is to develop and test a depression-specific marital therapy tailored for use with older adult populations.
Detailed Description
Major depression has been associated with many individual and interpersonal problems in later life, including inadequate social support, marital distress, spousal depression, poor physical health, and higher rates of mortality. Marital therapy has shown promise as a treatment for depression and coexisting marital distress in younger cohorts, and there is a robust association between social support and depressive symptoms in older adults. The combination of couple therapy and antidepressant medication may provide an ideal treatment for older adults by targeting interpersonal and biochemical aspects of depression. Couples interested in this study will complete an initial assessment with study personnel. In Phase I, eligible couples will receive weekly marital therapy and the depressed partner will receive medication management with a study doctor for 6 months. In Phase II, couples will be randomly assigned to either the combination treatment (marital therapy plus medication management) or medication management alone for 6 months. At the end of the treatment phase, a thorough assessment will be completed. A follow-up assessment will be completed 6 months after completion of treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Partner Relational Disorder (V61.10)
Keywords
Older Adults

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
Medication management with a study doctor every other week.
Arm Title
Combination
Arm Type
Experimental
Arm Description
Medication management with a study doctor every other week plus weekly marital therapy.
Intervention Type
Behavioral
Intervention Name(s)
Weekly marital therapy
Other Intervention Name(s)
Integrative Behavioral Couple Therapy
Intervention Description
Weekly marital therapy for 6 months.
Intervention Type
Drug
Intervention Name(s)
As indicated: Sertraline, bupropion, venlafaxine, mirtazepine, nortriptyline, tranylcypromine, lithium augmentation, etc.
Intervention Description
Study doctor may prescribe antidepressant medication for the treatment of depression. Medications will be prescribed according to empirically supported guidelines outlined in the Duke Somatic Treatment Algorithm for Geriatric Depression (STAGED Approach; Steffens, 2002). SSRIs (daily dose of at least 20 mg for citalopram, 20 mg for fluoxetine, 100 mg for sertraline, 20 mg for paroxetine) SNRIs (e.g., venlafaxine) Bupropion SR (achieve dose of at least 150 mg BID) Mirtazapine Tricyclic antidepressants (nortriptyline with drug levels 80-120 ng/dl) Lithium augmentation MAOI (daily dose of at least 30 mg tranylcypromine or 45 mg of phenelzine)
Primary Outcome Measure Information:
Title
Hamilton Depression Rating Scale (HDRS)
Description
The HDRS is a semi-structured interview administered by a trained independent evaluator, and used for rating the severity of depressive symptoms. Scores range from 0 to 50, with higher scores indicating greater severity of depression.
Time Frame
pre-treatment, monthly, post-treatment, 6 month follow-up
Title
Dyadic Adjustment Scale (DAS)
Description
The DAS is a self-report measure of marital adjustment that includes questions about agreement on lifestyle and household decisions, level of conflict, level of cooperation, and affection. Scores range from 0 to 151, with higher scores representing better relationship functioning.
Time Frame
pre-treatment, monthly, post-treatment, 6 month follow-up
Secondary Outcome Measure Information:
Title
Frequency & Acceptability of Partner Behavior
Time Frame
Pre-treatment, post-treatment, 6 month follow-up
Title
Conflict Tactics Scale
Time Frame
pre-treatment, post-treatment, 6 month follow-up
Title
SCID Mood Disorders
Time Frame
pre-treatment, post-treatment, 6 month follow-up
Title
Personal Assessment of Intimacy in Relationships
Time Frame
pre-treatment, post-treatment, 6 month-followup
Title
Beck Anxiety Inventory
Time Frame
pre-treatment, post-treatment, 6 month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: One partner must receive a clinical diagnosis of major depressive disorder based upon our assessment Couples must be living together Either partner must report marital distress or tension Willing to take antidepressant medication and participate in weekly marital therapy and assessments The depressed partner cannot be involved in any other psychosocial treatment Score above 24 on the Mini Mental Status Exam Exclusion Criteria: Both partners meet diagnostic criteria for major depressive disorder based on our evaluation Coexisting bipolar or psychotic disorder Evidence of a primary substance abuse or dependence disorder Current ECT treatment Evidence of active and severe domestic violence
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jill S. Compton, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Child & Family Studies Center; Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States

12. IPD Sharing Statement

Citations:
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Citation
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PubMed Identifier
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Treatment of Mood and Marriage Study (TOMMS)

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